Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome

NCT02538692 | Completed Phase 2 DMC

• 1 other identifier: 81373644
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the efficacy and safety of a traditional Chinese medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome (IBS-D).

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks.

  4 weeks after initiation of treatment

Secondary Outcomes (3)

• Stool frequency per week

  baseline(week 0), week 4, week 8, week 12

• An visual scale rating the degree of IBS-D symptoms

  baseline(week 0), week 4, week 8, week 12

• Proportion of adverse events

  week 4

Study Arms (2)

Tong-Xie-Yao-Fang

EXPERIMENTAL

Tong-Xie-Yao-Fang is a classic formula of traditional Chinese medicine for IBS-D. It is composed of 4 herbs: Radix Paeoniae Alba, Ledebouriella seseloides Wolff, pericarpium citri reticulatae and Rhizoma Atractylodis Macrocephalae. The granules will be administrated for thrice daily at a dose of 15g per time. The total duration of treatment is 4 weeks.

Drug: Tong-Xie-Yao-Fang

Placebo

PLACEBO COMPARATOR

It is a placebo that made with similar appearance and taste as the Tong-Xie-Yao-Fang granules.

Drug: Placebo

Interventions

Tong-Xie-Yao-Fang DRUG

Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.

Also known as: Tongxieyaofang

Tong-Xie-Yao-Fang

Placebo DRUG

The placebo is the same as Tong-Xie-Yao-Fang in appearance.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed as IBS according to the Rome III criteria;
• Diarrhea was present for at least 75% of the time;
• With a TCM differentiation as "liver stagnation and spleen defficiency"
• Had a colonoscopy within a year to rule out other bowel diseases.

You may not qualify if:

• Organic gastrointestinal disease, such as colorectal cancer, inflammatory bowel disease, advanced colonic polyp;
• Had gastrointestinal surgery within a year;
• Used durgs that affect gastrointestinal motility;
• Had psychological disorder;
• Serious disease in other system, which may bias the outcome measures.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Teaching Hospital of Chengdu University of TCM

Chengdu, Sichuan, 610075, China

Location

Related Publications (1)

• Chen M, Tang TC, Wang Y, Shui J, Xiao XH, Lan X, Yu P, Zhang C, Wang SH, Yao J, Zheng H, Huang DQ. Randomised clinical trial: Tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2018 Jul;48(2):160-168. doi: 10.1111/apt.14817. Epub 2018 Jun 1.

  PMID: 29856472 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2015
• First Posted: September 2, 2015
• Study Start: December 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

CN (1)